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Detection of Ileoanal Pouch/Reservoir Adenomas (DARIAC)

J

Jean Christophe Saurin

Status

Not yet enrolling

Conditions

Adenomatous Polyps

Treatments

Procedure: Adenomas detection rate with the different observation methods

Study type

Observational

Funder types

Other

Identifiers

NCT05954949
SFED 160

Details and patient eligibility

About

The detection of adenomas is the basis for the follow-up of patients with familial adenomatous polyposis, after colectomy, with a remnant rectum or an ileal pouch. The optimal method for the adenomas detection is not defined yet. Despite the proven effectiveness of indigo-carmine in different indications dye chromoendoscopy is not used in a consensual way at the international level. The situation of the ileal pouch is specific as adenomas have a usually flat shape and are much more difficult to identify than in the situation of a remnant rectum, even in the situation of > 5 mm adenomas that should be resected.

Our hypothesis is that indigo-carmine can improve adenomas detection, including > 5 mm adenomas, in patients with a an ileal pouch after colectomy improving the effectiveness of surveillance programs and potentially reducing the risk of cancer in this population.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with familial adenomatous polyposis
  • Ileo-anal anastomosis with pouch reservoir
  • Quality of the final preparation = 3 (excellent) on the studied area
  • Films made under optimal conditions for the 3 staining methods

Exclusion criteria

  • Patient with no familial adenomatous polyposis
  • Patient without Ileo-anal anastomosis reservoir
  • Insufficient quality of the final preparation <3
  • Absence of films made under optimal conditions for the 3 staining methods

Trial design

40 participants in 1 patient group

Ileoanal pouch adenomas detection assessment
Description:
Every patient who needs follow up lower digestive examination for familial adenomatous polyposis after colectomy can join this study with ileal pouch adenomas detection by experienced endoscopist.
Treatment:
Procedure: Adenomas detection rate with the different observation methods

Trial contacts and locations

0

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Central trial contact

Maira MORENO, PhD; Jean-Christophe SAURIN, Pr

Data sourced from clinicaltrials.gov

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